B COUNCILDIRECTIVE96/23/EC of29April1996 on measures to ...

1996L0023 — EN — 01.05.2004 — 002.001 — 1

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B COUNCIL DIRECTIVE 96/23/EC

of 29 April 1996

on measures to monitor certain substances and residues thereof in live animals and animalproducts and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and

91/664/EEC

(OJ L 125, 23.5.1996, p. 10)

Amended by:

Official Journal

No page date

►M1 Council Regulation (EC) No 806/2003 of 14 April 2003 L 122 1 16.5.2003

Amended by:

►A1 Act concerning the conditions of accession of the Czech Republic, theRepublic of Estonia, the Republic of Cyprus, the Republic of Latvia,the Republic of Lithuania, the Republic of Hungary, the Republic ofMalta, the Republic of Poland, the Republic of Slovenia and the SlovakRepublic and the adjustments to the Treaties on which the EuropeanUnion is founded

L 236 33 23.9.2003

▼BCOUNCIL DIRECTIVE 96/23/EC

of 29 April 1996

on measures to monitor certain substances and residues thereof inlive animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, andin particular Article 43 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Economic and SocialCommittee (3),

(1) Whereas by Directive 96/22/EC (4) the Council decided to main-tain the prohibition on the use of certain substances having ahormonal or thyrostatic action, by extending it to beta-agonistshaving an anabolic effect;

(2) Whereas on 9 March 1995 the European Parliament pointed out,inter alia, that the Community urgently needed an effective anduniform monitoring system and asked the Member States to rein-force supervision and monitoring with regard to the use of illegalsubstances in meat;

(3) Whereas, by Directive 85/358/EEC (5), the Council adoptedcertain rules on the detection and monitoring of substanceshaving a hormonal or thyrostatic action; whereas those rulesshould be extended to cover other substances which are used instockfarming to promote growth and productivity in livestock orfor therapeutic purposes and which may prove dangerous to theconsumer on account of their residues;

(4) Whereas by Directive 86/469/EEC (6), the Council introducedcertain rules on the monitoring of a certain number of residuesof pharmacological substances and of environmental contami-nants in farm animals and in the fresh meat obtained from suchanimals; whereas such monitoring should be extended to coverother animal species and all animal products for humanconsumption;

(5) Whereas Council Regulation (EEC) No 2377/90 of 26 June 1990laying down a Community procedure for the establishment ofmaximum residue limits of veterinary medicinal products infoodstuffs of animal origin (7) laid down in its Annexes limitsfor certain veterinary medicinal products;

(6) Whereas the Community legislation on monitoring residues inmeat lacks clarity, giving rise to varying interpretations in thedifferent Member States;

(7) Whereas there is a need to reinforce the controls carried out byand in the Member States;

(8) Whereas producers and others involved in the stockfarmingindustry should take greater responsibility in future for thequality and safety of meat for human consumption;

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(1) OJ No C 302, 9. 11. 1993, p. 12, and OJ No C 222, 10. 8. 1994, p. 17.(2) OJ No C 128, 9. 5. 1994, p. 100.(3) OJ No C 52, 19. 2. 1994, p. 30.(4) See p. 3 of this Official Journal.(5) OJ No L 191, 23. 7. 1985, p. 46. Directive as last amended by the 1994 Act

of Accession.(6) OJ No L 275, 26. 9. 1986, p. 36. Directive as amended by the 1994 Act of

Accession.(7) OJ No L 224, 18. 8. 1990, p. 1. Regulation as last amended by Commission

Regulation (EC) No 282/96 (OJ No L 37, 15. 2. 1996, p. 12).

▼B(9) Whereas the specific penalties in respect of stockfarmers not

complying with Community legislation in particular prohibitingthe use of certain hormonal and anabolic substances in stock-farming are to be incorporated in the separate provisionsgoverning particular product groups;

(10) Whereas Article 4 of Directive 71/118/EEC (1) requires MemberStates to ensure that checks are conducted to detect residues ofsubstances having a pharmacological action, their derivatives andother substances which may be transmitted to poultrymeat andwhich may make the consumption of fresh poultrymeatdangerous or harmful to human health;

(11) Whereas Directive 91/493/EEC (2) requires a monitoring systemto be established by the Member States to detect contaminantspresent in the aquatic environment;

(12) Whereas Directive 92/46/EEC (3) provides that, by 30 June 1993at the latest, national measures for the detection of residues inraw milk, heat-treated milk and milk-based products shall havebeen submitted to the Commission by the Member States, theresidues to be detected being those in Part A, group III, andPart B, group II, of Annex I to Directive 86/469/EEC;

(13) Whereas Directive 89/437/EEC (4) requires Member States toensure that checks are conducted to detect residues of substanceshaving a pharmacological or hormonal action, antibiotics, pesti-cides, detergents and other substances harmful or likely to alterthe organoleptic characteristics of egg products or make theconsumption of such products dangerous or harmful to humanhealth;

(14) Whereas Directive 92/45/EEC (5) requires Member States toextend their residue detection plans in order to make wild-gamemeat subject, where necessary, to sampling checks with a viewto detecting the presence of contaminants from the environmentand to include rabbits and farmed game in such monitoring;

(15) Whereas, if the illegal use of growth and productivity promotersin stockfarming is to be combated effectively in all MemberStates, action will have to be organized at Community level;

(16) Whereas systems of self-regulation by producer groups can playan important role in combating the illegal use of growth promo-ters; whereas it is essential for consumers that these systemsadequately guarantee the absence of such promoters and whereasa general European approach is essential to safeguard andsupport self-regulation systems;

(17) Whereas, to that end, producer groups should be assisted indeveloping self-regulation systems to ensure that their meat isfree of unauthorized substances or products;

(18) Whereas a certain number of provisions of Directives 86/469/EEC and 85/358/EEC and of Decisions 89/187/EEC (6) and 91/664/EEC (7) require clarification in the interests of the effectiveapplication of controls and residue detection in the Community;whereas, with a view to immediate and uniform application ofthe controls provided for, the present rules and amendments to

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(1) OJ No L 55, 8. 3. 1971, p. 23. Directive as last amended by the 1994 Act ofAccession.

(2) OJ No L 268, 24. 9. 1991, p. 15. Directive as last amended by Directive 95/71/EC (OJ No L 332, 30. 12. 1995, p. 40).

(3) OJ No L 268, 14. 9. 1992, p. 1. Directive as last amended by the 1994 Actof Accession.



(6) OJ No L 66, 10. 3. 1989, p. 37.(7) OJ No L 368, 31. 12. 1991, p. 17.

▼Bthem should be assembled in a single text repealing the aforesaidinstruments,

HAS ADOPTED THIS DIRECTIVE:

CHAPTER I

Scope and definitions

Article 1

This Directive lays down measures to monitor the substances andgroups of residues listed in Annex I.

Article 2

For the purposes of this Directive, the definitions in Directive 96/22/ECshall apply. In addition:

(a) ‘unauthorized substances or products’ shall mean substances orproducts the administering of which to animals is prohibited underCommunity legislation;

(b) ‘illegal treatment’ shall mean the use of unauthorized substances orproducts or the use of substances or products authorized underCommunity legislation for purposes or under conditions other thanthose laid down in Community legislation or, where appropriate, inthe various national legislations;

(c) ‘residue’ shall mean a residue of substances having a pharmacolo-gical action, of their metabolites and of other substancestransmitted to animal products and likely to be harmful to humanhealth;

(d) ‘competent authority’ shall mean the central authority of a MemberState competent in veterinary matters or any authority to whichsuch central authority has delegated such competence;

(e) ‘official sample’ shall mean a sample taken by the competentauthority which bears, for the purposes of examination of the resi-dues or substances listed in Annex I, a reference to the species, thetype, the quantity concerned, the method of collection and particu-lars identifying the sex of the animal and the origin of the animalor of the animal product;

(f) ‘approved laboratory’ shall mean a laboratory approved by thecompetent authorities of a Member State for the purposes of exam-ining an official sample in order to detect the presence of residues;

(g) ‘animal’ shall mean the species covered by Directive 90/425/EEC (1);

(h) ‘batch of animals’ shall mean a group of animals of the samespecies, in the same age range, reared on the same holding, at thesame time and under the same conditions of rearing;

(i) ‘beta-agonist’ shall mean a beta adrenoceptor agonist.

CHAPTER II

Monitoring plans for the detection of residues or substances

Article 3

The production process of animals and primary products of animalorigin shall be monitored in accordance with this Chapter for thepurpose of detecting the presence of the residues and substances listedin Annex I in live animals, their excrement and body fluids and intissue, animal products, animal feed and drinking water.

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(1) OJ No L 224, 18. 8. 1990, p. 29. Directive as last amended by Directive 92/65/EEC (OJ No L 268, 14. 9. 1992, p. 54).

▼BArticle 4

1. Member States shall assign the task of coordinating the imple-mentation of the inspections provided for in this Chapter, which arecarried out within their national territory, to a central public departmentor body.

2. The department or body referred to in paragraph 1 shall beresponsible for:

(a) drawing up the plan provided for in Article 5 to enable the compe-tent departments to carry out the required inspections;

(b) coordinating the activities of the central and regional departmentsresponsible for monitoring the various residues. Such coordinationshall extend to all departments working to prevent the fraudulentuse of substances or products on stock farms;

(c) collecting the data needed to evaluate the means used and theresults obtained in carrying out the measures provided for in thisChapter;

(d) sending the Commission, by not later than 31 March of each year,the data and results referred to in (c), including the results of anysurveys undertaken.

3. This Article shall not affect more specific rules applicable to themonitoring of animal nutrition.

Article 5

1. By 30 June 1997 at the latest, Member States shall submit a planto the Commission setting out the national measures to be implementedduring the initial year of the plan and subsequently any update of planspreviously approved in accordance with Article 8 on the basis of theexperience of the preceding year, or years by 31 March at the latestof the year of the update.

2. The plan provided for in paragraph 1 shall:

(a) provide for detection of groups of residues or substances accordingto type of animal, in accordance with Annex II;

(b) specify in particular the measures for detection of the presence of:

(i) the substances referred to in (a) in the animals, in the drinkingwater of the animals and in all places where the animals arebred or kept;

(ii) residues of the aforementioned substances in live animals, theirexcrement and body fluids and in animal tissues and productssuch as meat, milk, eggs and honey;

(c) comply with the sampling rules and levels laid down in AnnexesIII and IV.

Article 6

1. The plan must conform to the sampling levels and frequencieslaid down in Annex IV. However, at the request of a Member Statethe Commission may, in accordance with the procedure provided forin Article 32, adjust the minimum control requirements laid down inAnnex IV provided that it is clearly established that such adjustmentsincrease the overall effectiveness of the plan in respect of the MemberState concerned and in no way reduce its ability to identify residues of,or cases of illegal treatment with, substances listed in Annex I.

2. Re-examination of the groups of residues to be checked for inaccordance with Annex II and determination of the sampling levelsand frequencies covering the animals and products referred to inArticle 3 and not already laid down in Annex IV shall take place inaccordance with the procedure provided for in Article 33 and on thefirst occasion within a maximum of 18 months of the adoption of thisDirective. In doing so, account shall be taken of experience gainedunder existing national measures and information forwarded to the

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▼BCommission under existing Community requirements making suchspecific product groups subject to monitoring for residues.

Article 7

The initial plan shall take into account the specific situation of eachMember State and specify in particular:

— legislation on the use of the substances listed in Annex I and, inparticular, provisions on their prohibition or authorization, distribu-tion and placing on the market and the rules governing theiradministration, in so far as such legislation is not harmonized.

— the infrastructure of the relevant departments (in particular, givingdetails of the type and size of the bodies involved in implementingthe plans),

— a list of approved laboratories with details of their capacity forprocessing samples,

— national tolerances for authorized substances where no maximumCommunity residue levels have been set under Regulation (EEC)No 2377/90 and Directive 86/363/EEC (1),

— a list of the substances to be detected, methods of analysis, stan-dards for interpreting the findings and, in the case of thesubstances listed in Annex I, the number of samples to be taken,giving reasons for this number,

— the number of official samples to be taken in relation to the numberof animals of the species concerned slaughtered in preceding yearsin accordance with the sampling levels and frequencies laid downin Annex IV,

— details of the rules governing the collection of official samples, andin particular the rules concerning the particulars to appear on suchofficial samples,

— the type of measures laid down by the competent authorities withregard to animals or products in which residues have been detected.

Article 8

1. The Commission shall examine the initial plans forwardedpursuant to Article 5 (1) to ascertain whether they conform to thisDirective. The Commission may ask a Member State to modify orsupplement these plans to make them conform.

Once the Commission has established their conformity, it shall submitthe plans for approval in accordance with the procedure provided for inArticle 33.

In order to take account of changes in the situation in a given MemberState or in a region thereof, of the results of national surveys or ofinvestigations carried out in the framework of Articles 16 and 17, theCommission may, at the request of the Member State concerned or onits own initiative, decide, in accordance with the procedure providedfor in Article 32, to approve an amendment or addition to a planpreviously approved pursuant to paragraph 2.

2. Annual amendments to the initial plans communicated by theMember States, in particular in the light of the results referred to inArticle 4 (2) (d), shall be forwarded by the Commission to the otherMember States once the Commission has established their conformitywith this Directive.

Member States shall have 10 working days from receipt of thoseamendments in which to inform the Commission of any comments.

If there are no comments from Member States, the amendments to theplans shall be deemed to be approved.

The Commission shall inform the Member States of such approvalimmediately.

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▼BWhere there are comments from Member States or where the Commis-sion deems the update not to be in conformity or insufficient, theCommission shall submit the updated plans to the Standing VeterinaryCommittee, which must act under the procedure laid down in Article33.

The provisions laid down in paragraph 3 and 4 shall apply to theupdated plans.

3. Every six months, Member States shall inform the Commissionand the other Member States within the Standing VeterinaryCommittee of the implementation of plans approved pursuant to para-graph 2 or of the development of the situation. Where necessary,paragraph 4 shall apply. By not later than 31 March each year, MemberStates shall forward to the Commission the results of their residue andsubstance detection plans and of their control measures.

The Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary,Malta, Poland, Slovenia and Slovakia shall, for the first time by31 March 2005, forward to the Commission the results of their residueand substance detection plans and of their control measures.

Member States shall make public the outcome of the implementation ofthe plans.

The Commission shall inform Member States, within the StandingVeterinary Committee, of developments in the situation in the variousregions of the Community.

4. Each year, or whenever it deems it necessary on public healthgrounds, the Commission shall report to Member States within theStanding Veterinary Committee on the outcome of the checks andsurveys referred to in paragraph 3, in particular on:

— the implementation of national plans,— developments in the situation in the various regions of the Commu-

nity.

5. The Commission shall send the European Parliament and theCouncil a communication each year on the results of action taken atregional, national or Community level, bearing in mind the report andMember States' comments on it.

CHAPTER III

Self-monitoring and co-responsibility on the part of operators

Article 9

A. Member States shall ensure that:

1. any farms which place farm animals on the market and anynatural or legal person engaged in trade in such animals registerbeforehand with the competent authorities and undertake to abideby the relevant Community and national rules, in particular theprovisions laid down in Articles 5 and 12 of Directive 90/425/EEC;

2. the owners or persons in charge of the establishment of initialprocessing of primary products of animal origin take all neces-sary measures, in particular by carrying out their own checks, to

(a) accept — whether by direct delivery or through an inter-mediary — only those animals for which the producer isable to guarantee that withdrawal times have been observed;

(b) satisfy themselves that the farm animals or products broughtinto the establishment

(i) do not contain residue levels which exceed maximumpermitted limits;

(ii) do not contain any trace of prohibited substances orproducts;

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▼A1

▼B

▼B3. (a) the producers or persons in charge referred to in points 1 and

2 place on the market only:

(i) animals to which no unauthorized substances orproducts have been administered or which have notundergone illegal treatment within the meaning of thisDirective;

(ii) animals in respect of which, where authorized productsor substances have been administered, the withdrawalperiods prescribed for these products or substanceshave been observed;

(iii) products derived from the animals referred to in (i) and(ii);

(b) where an animal is presented at a first-stage processingestablishment by a natural or legal person other than theproducer, the obligations laid down in (a) are incumbent onthe latter.

B. For the purposes of applying point A, Member States shall ensure,without prejudice to compliance with the rules laid down in theDirectives governing the placing on the market of the variousproducts in question, that:

— the principle of quality monitoring of the production chain bythe different parties involved is established in their legislation,

— the self-monitoring measures to be included in the specificationsfor trade marks or labels are stepped up.

They shall inform the Commission and the other Member States, attheir request, of provisions laid down in this regard and in particularof provisions adopted for checks on point A (3) (a) (i) and (ii).

Article 10

Member States shall ensure that the terms of reference and responsibil-ities of veterinarians monitoring farms are extended to monitoring therearing conditions and the forms of treatment referred to in this Direc-tive.

Within this framework, the veterinarian shall enter in a register kept onthe farm the date and nature of any treatment prescribed or adminis-tered, the identification of the animals treated and the correspondingwithdrawal periods.

The stockfarmer shall enter in the register, which may be the registerprovided for in Directive 90/676/EEC (1), the date and nature of thetreatment administered. He shall satisfy himself that withdrawal periodshave been observed and keep the prescriptions to prove it for fiveyears.

Stockfarmers and veterinarians shall be required to supply any informa-tion to the competent authority, at its request, and in particular supplyinformation to the official veterinarian of the slaughterhouse, regardinga given farm's compliance with the requirements of this Directive.

CHAPTER IV

Official control measures

Article 11

1. Without prejudice to the checks carried out in connection withimplementation of the surveillance plans referred to in Article 5 or tothe checks provided for in specific Directives, Member States mayhave official random checks conducted:

(a) during the manufacture of the substances included in Group A inAnnex I and during their handling, storage, transport, distributionand sale or acquisition;

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(1) OJ No L 373, 31. 12. 1990, p. 15.

▼B(b) at any point in the animal feedingstuffs production and distribution

chain;

(c) throughout the production chain of animals and raw materials ofanimal origin covered by this Directive.

2. The checks provided for in paragraph 1 must be conducted with aview in particular to detecting the possession or presence of prohibitedsubstances or products which it is intended to administer to animals forthe purposes of fattening or illegal treatment.

3. Where fraud is suspected, and in the case of a positive result fromany of the checks referred to in paragraph 1, Articles 16 to 19 and themeasures provided for in Chapter V shall apply.

The checks provided for at the slaughterhouse or on the first sale ofaquaculture animals and fishery products can be reduced to takeaccount of the fact that the farm of origin or departure belongs to anepidemiological surveillance network or a quality monitoring systemas referred to in the first indent of the first subparagraph of Article 9(B).

Article 12

The checks provided for in this Directive must be carried out by thecompetent national authorities without prior notice.

The owner, the person empowered to dispose of the animals or theirrepresentative shall be obliged to facilitate pre-slaughter inspectionoperations, and in particular to assist the official veterinarian or theauthorized staff in any manipulation judged necessary.

Article 13

The competent authority shall:

(a) where illegal treatment is suspected, ask the owner or personhaving charge of the animals or the veterinarian in charge of thefarm to provide any documentation justifying the nature of thetreatment;

(b) where this inquiry confirms illegal treatment or where unauthorizedsubstances or products have been used, or where there are groundsfor suspecting their use, conduct or have conducted:

— spot checks on animals on their farms of origin or departure, inparticular with a view to detecting such use and in particularany traces of implants; these checks may include officialsampling,

— checks to detect substances the use of which is prohibited or ofunauthorized substances or products on the farms where theanimals are being reared, kept or fattened (including holdingsadministratively connected with such farms) or on the animals'farms of origin or departure. Official samples of drinking waterand feedingstuffs are necessary for that purpose.

— spot checks on animals' feedingstuffs on their farms of origin ordeparture, and on their drinking water or — for aquacultureanimals — from the waters in which they are caught,

— the checks provided for in Article 11 (1) (a),

— any check required to clarify the origin of the unauthorizedsubstances or products or that of the treated animals;

(c) where the maximum levels laid down by Community rules or,pending such legislation, the levels set by national legislation havebeen exceeded, carry out any measure or investigation which itmay deem appropriate in relation to the finding in question.

Article 14

1. Each Member State shall designate at least one national referencelaboratory. A given residue or residue group may not be assigned tomore than one national reference laboratory.

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▼BHowever, until 31 December 2000, Member States may continue toentrust testing for the same residue or residue group to several nationallaboratories which they designated prior to the date of adoption of thisDirective.

A list of such designated laboratories shall be drawn up in accordancewith the procedure laid down in Article 33.

These laboratories shall be responsible for:

— coordinating the work of the other national laboratories responsiblefor residue analysis, in particular by coordinating the standards andmethods of analysis for each residue or residue group concerned,

— assisting the competent authority in organizing the plan for moni-toring residues,

— periodically organizing comparative tests for each residue or residuegroup assigned to them,

— ensuring that national laboratories observe the limits laid down,

— disseminating information supplied by Community reference labora-tories,

— ensuring that their staff are able to take part in further trainingcourses organized by the Commission or by Commission referencelaboratories.

2. The Community reference laboratories shall be those designatedin Chapter 1 of Annex V.

The powers and working conditions of the laboratories shall be asdefined in Chapter 2 of Annex V.

Article 15

1. Official samples must be taken in accordance with Annexes IIIand IV in order to be examined in approved laboratories.

The detailed rules for the taking of official samples and the routine andreference methods to be employed for the analysis of such officialsamples shall be specified in accordance with the procedure laid downin Article 33.

Whenever an authorization is issued for the placing on the market of aveterinary medicinal product intended for administration to a speciesthe meat or product of which is intended for human consumption, thecompetent authorities shall forward the routine analysis methods as laiddown in Article 5, second subparagraph, point 8 of Directive 81/851/EEC (1) and Article 7 of Regulation (EEC) No 2377/90 to the Commu-nity and national reference laboratories for detection of residues.

2. For Group A substances, all positive findings recorded followingthe application of a routine method instead of a reference method mustbe confirmed by an approved laboratory using the reference methodslaid down in accordance with paragraph 1.

For all substances, if challenged on the basis of a contradictoryanalysis, those results must be confirmed by the national referencelaboratory designated in accordance with Article 14 (1) for thesubstance or residue in question. Such confirmation must be carriedout at the plaintiff's cost in the event of confirmation.

3. Where examination of an official sample reveals illegal treatment,Articles 16 to 19 shall apply, together with the measures laid down inChapter V.

Where the examination reveals the presence of residues of authorizedsubstances or contaminants exceeding the levels set by Communityrules or, pending such legislation, the levels set by national legislation,Articles 18 and 19 shall apply.

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(1) OJ No L 317, 6. 11. 1981, p. 1. Directive as last amended by Directive 93/40/EEC (OJ No L 214, 24. 8. 1993, p. 31).

▼BWhere the examination referred to in this paragraph covers animals orproducts of animal origin from another Member State, the competentauthority of the Member State of origin shall apply Articles 16 (2),17, 18 and 19 and the measures provided for in Chapter V to the farmor establishment of origin or departure, following the reasoned requestof the competent authority having carried out the examination.

Where the examination covers products or animals imported from athird country, the competent authority having carried out that examina-tion shall refer the matter to the Commission, which shall take themeasures provided for in Article 30.

Article 16

Member States shall ensure that, where positive results are obtained asdescribed in Article 15:

1. the competent authority shall obtain without delay:

(a) all the information required to identify the animal and farm oforigin or departure;

(b) full details of the examination and its result. If the controlscarried out in a Member State demonstrate the need for aninvestigation or other action in one or more Member States orthird countries, the Member State concerned shall inform theother Member States and the Commission. The Commissionshall coordinate the appropriate measures taken in MemberStates where an investigation or other action proves necessary;

2. the appropriate authority shall carry out:

(a) an investigation on the farm of origin or departure, as appro-priate, to determine the reasons for the presence of residues;

(b) in the case of illegal treatment, an investigation of the source orsources of the substances or products concerned at the stage ofmanufacture, handling, storage, transport, administration, distri-bution or sale, as appropriate;

(c) any other further investigations which the authority considersnecessary;

3. animals from which samples have been taken are clearly identified.They may not in any circumstances leave the farm until the resultsof the checks are available.

Article 17

Where illegal treatment is established, the competent authority mustensure that the livestock concerned in the investigations referred to inpoint (b) of Article 13 is immediately placed under official control. Itmust furthermore ensure that all the animals concerned bear an officialmark or identification and that, as a first step, an official sample istaken from a statistically representative sample, on internationallyrecognized scientific bases.

Article 18

1. Where there is evidence of residues of authorized substances orproducts of a level exceeding the maximum limit for residues, thecompetent authority shall carry out an investigation in the farm oforigin or departure, as applicable, to determine why the above limitwas exceeded.

In accordance with the results of that investigation, the competentauthority shall take all necessary measures to safeguard public healthwhich may include prohibiting animals from leaving the farmconcerned or products from leaving the farm or establishmentconcerned for a set period.

2. In the event of repeated infringements of maximum residue limitswhen animals are placed on the market by a farmer or products areplaced on the market by a farmer or a processing establishment, inten-sified checks on the animals and products from the farm and/or

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▼Bestablishment in question must be carried out by the competent autho-rities for a period of at least six months, products or carcases beingimpounded pending the results of analysis of the samples.

Any results showing that the maximum residue limit has been exceededmust lead to the carcases or products concerned being declared unfitfor human consumption.

Article 19

1. The costs of the investigations and checks referred to in Article16 shall be borne by the owner or person having charge of the animals.

Where the investigation confirms that suspicion was justified, the costsof analyses carried out under Articles 17 and 18 shall be borne by theowner or person having charge of the animals.

2. Without prejudice to criminal or administrative penalties, the costof destroying animals which have given a positive result or animalswhich have been deemed positive in accordance with Article 23 shallbe borne by the owner of the animals without indemnity or compensa-tion.

Article 20

1. Council Directive 89/608/EEC of 21 November 1989 on mutualassistance between the administrative authorities of the Member Statesand cooperation between the latter and the Commission to ensure thecorrect application of legislation on veterinary and zootechnicalmatters (1) shall apply for the purposes of this Directive.

2. Where a Member State considers that, in another Member State,the controls provided for in this Directive are not being, or have ceasedto be, carried out, it shall inform the competent central authority of thatState accordingly. Following an investigation carried out in accordancewith point 2 of Article 16, that authority shall take all necessarymeasures and shall, at the earliest opportunity notify the competentcentral authority, of the first Member State of the decisions taken andthe reasons for those decisions.

If the first Member State fears that such measures are not being takenor are inadequate, it shall, together with the Member State which hasbeen challenged, seek ways and means of remedying the situation; ifappropriate, this may involve an on-the-spot inspection.

Member States shall inform the Commission of disputes and of solu-tions arrived at.

If the Member States involved in a dispute are unable to reach agree-ment, one of them shall bring the matter to the notice of theCommission within a reasonable period of time, and the latter shallinstruct one or more experts to deliver an opinion.

Pending that opinion, the Member State of destination may carry outchecks on products coming from the establishment(s) or holding(s) towhich the dispute relates and, if the result is positive, take measuressimilar to those provided for in Article 7 (1) (b) of Directive 89/662/EEC (2).

In the light of the experts' opinion, appropriate measures may be takenin accordance with the procedure provided for in Article 32.

Those measures may be reviewed in accordance with the same proce-dure, in the light of a new expert opinion delivered within 15 days.

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(1) OJ No L 351, 2. 12. 1989, p. 34.(2) OJ No L 395, 30. 12. 1989, p. 13. Directive as last amended by Directive

92/67/EEC (OJ No L 268, 14. 9. 1992, p. 73).

▼BArticle 21

1. To the extent necessary to ensure uniform application of thisDirective, and in cooperation with the competent authorities of theMember States, the Commission's veterinary experts may verify onthe spot that the plans and the system for checking the plans by thecompetent authorities have been uniformly implemented. A MemberState within whose territory a verification is being carried out shallgive all necessary assistance to the experts in carrying out their duties.The Commission shall inform the Member State concerned of theresults of the verifications carried out.

The Member State concerned shall take the measures necessary to takeaccount of the results of these verifications and shall notify theCommission of the measures taken. Where the Commission considersthat the measures taken are insufficient, it shall, after consultationwith the Member State in question and having regard to the measuresnecessary to safeguard public health, take appropriate measures inaccordance with the procedure laid down in Article 32.

2. The general rules for implementing this Article, especially asregards the frequency and method of carrying out the verificationsreferred to in the first subparagraph of paragraph 1 (including coopera-tion with the competent authorities), shall be determined in accordancewith the procedure laid down in Article 33.

CHAPTER V

Measures to be taken in the event of infringement

Article 22

Where unauthorized substances or products or substances listed inGroup A and Group B (1) and (2) of Annex I are discovered in thepossession of non-authorized persons, those unauthorized substancesor products must be placed under official control until appropriatemeasures are taken by the competent authority, without prejudice tothe possible imposition of penalties on the offender(s).

Article 23

1. During the period in which animals are impounded as providedfor in Article 17, animals from the farm in question may not leave thefarm of origin or be handed over to any other person except under offi-cial control. The competent authority shall take appropriateprecautionary measures in accordance with the nature of the substanceor substances identified.

2. After sampling has been carried out in accordance with Article17, if there is confirmation of a case of illegal treatment, the animalor animals found to be positive shall be slaughtered immediately onthe spot or taken immediately to the designated slaughterhouse or tothe knacker's yard under cover of an official veterinary certificate inorder to be slaughtered there. Animals so slaughtered shall be sent toa high-risk processing plant as defined by Directive 90/667/EEC (1).

In addition, samples must be taken at the farm's expense from theentire batch of animals belonging to the farm at which checks werecarried out and which may be suspect.

3. However, if half or more of the samples taken by representativesampling in accordance with Article 17 are positive, the farmer may beleft a choice between a check on all the animals present on the farmwhich may be suspect, or slaughter of these animals.

4. For a further period of at least 12 months, the farm(s) belongingto the same owner shall be subject to more stringent checks for theresidues in question. Where an organized system of self-monitoring

1996L0023 — EN — 01.05.2004 — 002.001 — 13

(1) OJ No L 363, 27. 12. 1990, p. 51. Directive as last amended by the 1994Act of Accession.

▼Bhas been set up, this facility shall be withdrawn from the farmer forthat period.

5. In view of the infringement recorded, the farms or establishmentssupplying the holding concerned shall be subject to checks in additionto those provided for in Article 11 (1) to determine the origin of thesubstance in question. The same shall apply to all farms and establish-ments in the same supply chain of animals and animal feed as the farmof origin or departure.

Article 24

The official veterinarian of a slaughterhouse must:

1. if he suspects or has evidence that the animals concerned have beensubjected to illegal treatment or that unauthorized substances orproducts have been administered to them:

(a) arrange for the animals to be slaughtered separately from otherbatches of animals arriving at the slaughterhouse;

(b) impound the carcases and offal and carry out all sampling proce-dures necessary to detect the substances in question;

(c) if positive results are obtained, send the meat and offal to ahigh-risk processing plant as defined by Directive 90/667/EEC,without indemnity or compensation.

In that event, Articles 20 to 23 shall apply;

2. if the suspects or has evidence that the animals concerned have beensubjected to an authorized treatment but that the withdrawal periodshave not been complied with, postpone slaughter of the animalsuntil he can be satisfied that the quantity of residues does not exceedthe permitted levels.

This period may in no circumstances be less than the withdrawalperiod laid down in point (b) of Article 6 (2) of Directive 96/22/EC for the substances in question, or than the withdrawal periodsprovided for in the marketing authorization.

However, in an emergency or where required for the well-being ofthe animals, or if the infrastructure or equipment of the slaughter-house is such that slaughter cannot be deferred, the animals may beslaughtered before the end of the ban or postponement period. Themeat and offal shall be impounded pending the outcome of the offi-cial checks carried out by the slaughterhouse's official veterinarian.Only meat and offal containing a quantity of residues not exceedingthe permitted levels shall be used for human consumption;

3. declare unfit for human consumption carcases and products in whichthe residue level exceeds the levels authorized by Community ornational regulations.

Article 25

Without prejudice to criminal penalties, where the holding, use ormanufacture of unauthorized substances or products in a manufacturingestablishment is confirmed, any authorizations or official approvalarrangements enjoyed by the establishment concerned shall besuspended for a period during which the establishment shall besubjected to more stringent checks.

In the case of a repeated offence, such authorizations or approvalarrangements shall be permanently withdrawn.

Article 26

Rights of appeal allowed by national legislation in force in the MemberStates against decisions taken by the competent authorities under Arti-cles 23 and 24 shall not be affected by this Directive.

1996L0023 — EN — 01.05.2004 — 002.001 — 14

▼BArticle 27

Without prejudice to criminal penalties, or penalties imposed by profes-sional bodies, appropriate administrative measures must be takenagainst any person where he is responsible, as the case may be, forthe transfer or administering of prohibited substances or products orfor the administering of authorized substances or products for purposesother than those laid down in the current legislation.

Article 28

Any failure to cooperate with the competent authority and any obstruc-tion by slaughterhouse personnel or the slaughterhouse supervisor or, inthe case of a private enterprise, by the slaughterhouse owner or owners,or by the owner of the animals or person having charge of them, duringinspection and sampling as required for the implementation of nationalplans for monitoring residues and during the investigations and checksprovided for in this Regulation, shall result in appropriate criminal and/or administrative penalties being imposed by the competent nationalauthorities.

If it is proven that a slaughterhouse owner or supervisor is helping toconceal the illegal use of prohibited substances, the Member State shalldeny the guilty party any opportunity of receiving or applying forCommunity aid for a period of 12 months.

CHAPTER VI

Imports from third countries

Article 29

1. Inclusion and retention on the lists of third countries provided forin Community legislation from which Member States are authorized toimport animals and animal products covered by this Directive shall besubject to submission by the third country concerned of a plan settingout the guarantees which it offers as regards the monitoring of thegroups of residues and substances referred to in Annex I. This planmust be updated at the request of the Commission, particularly whenthe checks referred to in paragraph 3 render it necessary.

The provisions of Article 8 concerning time limits for submission andupdating of plans shall apply for plans to be submitted by third coun-tries.

The guarantees must have an effect at least equivalent to thoseprovided for in this Directive and must, in particular, meet the require-ments of Article 4 and specify the particulars laid down in Article 7 ofthis Directive and meet the requirements of Article 11 (2) of Directive96/22/EC.

The Commission shall approve the plan in accordance with the proce-dure laid down in Article 33. Under the same procedure, guaranteesalternative to those resulting from the implementation of this Regula-tion may be accepted.

2. Where the requirements of paragraph 1 are not complied with,inclusion of a third country on the lists of third countries laid downby Community legislation or as a result of the benefit of pre-listingmay be suspended in accordance with the procedure laid down inArticle 33, at the request of a Member State or by the Commission onits own initiative.

1996L0023 — EN — 01.05.2004 — 002.001 — 15

▼B3. Compliance with the requirements of and adherence to the guar-antees offered by the plans submitted by third countries shall beverified by means of the checks referred to in Article 5 of Directive72/462/EEC (1) and the checks provided for in Directives 90/675/EEC (2) and 91/496/EEC (3).

4. Member States shall inform the Commission each year of theresults of residue checks carried out on animals and animal productsimported from third countries, in accordance with Directives 90/675/EEC and 91/496/EEC.

Article 30

1. Where the checks provided by Directives 90/675/EEC and 91/496/EEC reveal the use of unauthorized products or substances for thetreatment of the animals in a given batch — batch within the meaningof Article 2 (2) (e) of Directive 91/496/EEC — or the presence of suchproducts or substances in all or part of a batch originating in the sameestablishment, the competent authority shall take the followingmeasures in respect of the animals and products involved in such use:

— it shall inform the Commission of the nature of the products usedand the batch concerned; the Commission shall forthwith informall frontier posts,

— the Member States shall carry out more stringent checks on allbatches of animals or products from the same source. In particular,the next 10 batches from the same source must be impounded —and a deposit lodged against inspection costs — at the frontierinspection post for a check on residues by taking a representativesample of each batch or of the part of the batch.

Where such additional checks demonstrate the presence ofunauthorized substances or products or of residues of suchsubstances or products:

(i) the batch or the part of the batch concerned must be returned tothe country of origin at the expense of the consignor or hisagent with a clear indication on the certificate of the reasonsfor rejecting the batch;

(ii) depending on the nature of the infringement found and the riskassociated with such an infringement, it must be left to theconsignor to decide whether to send back the batch or part ofthe batch concerned, to destroy it or to use it for other purposesauthorized by Community legislation, without indemnity orcompensation;

— the Commission shall be informed of the outcome of the more strin-gent checks and on the basis of this information shall make allnecessary investigations, to identify the reasons for and origins ofthe infringements found.

2. Where the checks provided for by Directive 90/675/EEC revealthat the maximum residue limits have been exceeded, use shall bemade of the checks referred to in the second indent of paragraph 1.

3. If, in cases involving third countries which have concludedequivalence agreements with the Community, the Commission, aftermaking enquiries of the competent authorities of the third countriesconcerned, concludes that they have failed to fulfil their obligationsand the guarantees given by the plans referred to in Article 29 (1), itshall cease to allow that country, under the procedure laid down inArticle 32, to benefit from the said agreements for the animals andproducts in question until the third country in question has made goodits shortcomings. The suspension shall be revoked under the sameprocedure.

1996L0023 — EN — 01.05.2004 — 002.001 — 16

(1) OJ No L 302, 31. 12. 1972, p. 28. Directive as last amended by the 1994Act of Accession.



▼BIf necessary, in order to re-establish the benefit afforded by the saidagreements, a Community deputation including experts from theMember States shall visit the country concerned, at that country'sexpense, in order to verify that such measures have been taken.

CHAPTER VII

General provisions

Article 31

The Council, acting on a proposal from the Commission, shall amendDirective 85/73/EEC (1) before 1 July 1997 in order to provide for thecharging of a fee to cover monitoring carried out pursuant to thisDirective.

Pending that decision by the Council, Member States shall be author-ized to charge national fees to cover the actual costs of suchmonitoring.

Article 32

1. Where the procedure laid down in this Article is to be followed,matters shall be referred without delay to the Standing VeterinaryCommittee set up by Decision 68/361/EEC (2), by its Chairman, eitheron his own initiative or at the request of a Member State.

2. The Commission representative shall submit a draft of themeasures to be taken. The Committee shall deliver its opinion on thosematters within a time limit which the Chairman may set according tothe urgency of the matter submitted. Opinions shall be delivered by amajority of 62 votes.

3. (a) The Commission shall adopt the measures and implement themimmediately where they are in accordance with the opinion ofthe Committee.

(b) Where they are not in accordance with the opinion of theCommittee, or if no opinion is delivered, the Commission shallforthwith submit to the Council a proposal concerning themeasures to be taken. The Council shall adopt the measures bya qualified majority.

If, 15 days after the proposals were submitted to it, the Council has notadopted any measures, the Commission shall adopt the measuresproposed and implement them immediately unless the Council hasrejected those measures by a simple majority.

Article 33

1. The Commission shall be assisted by the Standing Committee onthe Food Chain and Animal Health set up pursuant to Article 58 ofRegulation (EC) No 178/2002 (3).

2. Where reference is made to this Article, Articles 5 and 7 of Deci-sion 1999/468/EC (4) shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC shall beset at three months.

1996L0023 — EN — 01.05.2004 — 002.001 — 17


(2) OJ No L 255, 18. 10. 1968, p. 23.(3) OJ L 31, 1.2.2002, p. 1.(4) OJ L 184, 17.7.1999, p. 23.

▼M1

▼BArticle 34

Without prejudice to Article 6 (2), Annexes I, III, IV and V may beamended or supplemented by the Council acting by a qualified majorityon a proposal from the Commission.

In particular, the aforementioned Annexes may be amended withinthree years of the date of adoption of this Directive, with a view torisk assessment of the following factors:

— potential toxicity of residues in foodstuffs of animal origin,— likelihood of residues occurring in foodstuffs of animal origin.

Article 35

The Council, acting by a qualified majority on a proposal from theCommission, may adopt transitional measures required for the imple-mentation of the arrangements laid down by this Directive.

Article 36

1. Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC are hereby repealed as from 1 July 1997.

2. The following are also repealed as from the said date:

(a) Article 4 (3) of Directive 71/118/EEC;

(b) Article 5 (3) and (4) of Directive 89/437/EEC;

(c) the last subparagraph of point II.3.B of Chapter V of the Annex toDirective 91/493/EEC;

(d) Article 11 (1) of Directive 92/45/EEC;

(e) Article 15 (1) of Directive 92/46/EEC.

3. References to Directives and Decisions which have been repealedshall be deemed to be references to this Directive and shall be read inaccordance with the correlation table in Annex VI.

Article 37

1. Member States shall bring into force the laws, regulations andadministrative provisions necessary to comply with this Directivebefore 1 July 1997.

When Member States adopt these measures, they shall contain a refer-ence to this Directive or shall be accompanied by such reference on theoccasion of their official publication. The methods of making suchreference shall be laid down by Member States.

2. Member States shall communicate to the Commission the texts ofthe main provisions of national law which they adopt in the fieldgoverned by this Directive.

Article 38

This Directive shall enter into force on the day of its publication in theOfficial Journal of the European Communities.

Article 39

This Directive is addressed to the Member States.

1996L0023 — EN — 01.05.2004 — 002.001 — 18

▼BANNEX I

GROUP A — Substances having anabolic effect and unauthorizedsubstances

(1) Stilbenes, stilbene derivatives, and their salts and esters

(2) Antithyroid agents

(3) Steroids

(4) Resorcylic acid lactones including zeranol

(5) Beta-agonists

(6) Compounds included in Annex IV to Council Regulation (EEC) No 2377/90of 26 June 1990

GROUP B — Veterinary drugs (1) and contaminants

(1) Antibacterial substances, including sulphonomides, quinolones

(2) Other veterinary drugs

(a) Anthelmintics

(b) Anticoccidials, including nitroimidazoles

(c) Carbamates and pyrethroids

(d) Sedatives

(e) Non-steroidal anti-inflammatory drugs (NSAIDs)

(f) Other pharmacologically active substances

(3) Other substances and environmental contaminants

(a) Organochlorine compounds including PcBs

(b) Organophosphorus compounds

(d) Chemical elements

(d) Mycotoxins

(e) Dyes

(f) Others

1996L0023 — EN — 01.05.2004 — 002.001 — 19

(1) Including unlicensed substances which could be used for veterinary purposes.

▼BANNEX II

RESIDUE OR SUBSTANCE GROUP TO BE DETECTED BY TYPE OF ANIMAL, THEIRFEEDINGSTUFFS, INCLUDING DRINKING WATER, AND PRIMARY ANIMAL

PRODUCTS

Type ofanimal,feeding-stuffs oranimalproductsSubstancegroups

Bovine,ovine,caprine,porcine,equineanimals

PoultryAquacul-

tureanimals

Milk Eggs

Rabbitmeat and

the meat ofwild (*)

game andfarmedgame

Honey

A 1 X X X X

2 X X X

3 X X X X

4 X X X

5 X X X

6 X X X X X X

B 1 X X X X X X X

2a X X X X X

b X X X X

c X X X X

d X

e X X X X

f

3a X X X X X X X

b X X X

c X X X X X X

d X X X X

e X

f

(*) Only chemical elements are relevant where wild game is concerned.

1996L0023 — EN — 01.05.2004 — 002.001 — 20

▼BANNEX III

SAMPLING STRATEGY

1. The residue control plan is aimed at surveying and revealing the reasons forresidue hazards in foods of animal origin on farms, slaughterhouses, dairies,fish processing plants, and egg collecting and packing stations.

Official samples are to be taken in accordance with the relevant chapter ofAnnex IV.

Wherever official samples are taken, sampling must be unforeseen, unex-pected and effected at no fixed time and on no particular day of the week.The Member States must take all the precautions necessary to ensure thatthe element of surprise in the checks is constantly maintained.

2. For Group A substances, surveillance should be aimed at detecting the illegaladministration of prohibited substances and the abusive administration ofapproved substances, respectively. The emphasis of such sampling must beconcentrated according to the relevant chapter of Annex IV.

The samples must be targeted taking account of the following minimumcriteria: sex, age, species, fattening system, all available background informa-tion, and all evidence of misuse or abuse of substances of this group.

The details of these criteria will be laid down in the Commission Decisionprovided for in Article 15 (1).

3. For Group B substances, surveillance should be aimed particularly at control-ling the compliance with MRLs for residues of veterinary medicinal productsfixed in Annexes I and III to Regulation (EEC) No 2377/90, and themaximum levels of pesticides fixed in Annex III to Directive 86/363/EEC,and monitoring the concentration of environmental contaminants.

Unless random sampling can be justified by Member States when presentingtheir national plans to the Commission, all the samples shall be targetedaccording to criteria laid down in the Commission Decision provided for inArticle 15 (1).

1996L0023 — EN — 01.05.2004 — 002.001 — 21

▼BANNEX IV

SAMPLING LEVELS AND FREQUENCY

The purpose of this Annex is to define the minimum number of animals fromwhich the samples must be taken.

Each sample can be analysed for detecting the presence of one or moresubstances.

CHAPTER 1

Bovine, porcine, ovine, caprine and equine animals

1. Bovine animals

The minimum number of animals to be controlled each year for all kinds ofresidues and substances must at least equal 0,4 % of bovine animals slaugh-tered the previous year, with the following breakdown:

Group A: 0,25 % divided as follows:

— one half of the samples are to be taken from live animals on the holding;

(by derogation, 25 % of samples analysed for the research of Group A 5substances can be taken from appropriate material (feedingstuffs, drinkingwater, etc.))

— one half of the samples are to be taken at the slaughterhouse.

Each sub-group in Group A must be checked each year using a minimum of5 % of the total number of samples to be collected for Group A.

The balance must be allocated according to the experience and backgroundinformation of the Member State.

Group B: 0,15 %

30 % of the samples must be checked for Group B 1 substances.



The balance must be allocated according to the situation of the MemberState.

2. Porcine animals

The minimum number of animals to be checked each year for all kinds ofresidues and substances must at least equal 0,05 % of the pigs slaughteredthe previous year, with the following breakdown:

Group A: 0,02 %

In those Member States which carry out their sampling of animals at theslaughterhouse, in addition analysis of drinking water, feedingstuffs, faeces,or all other appropriate parameters must be undertaken at farm level. In thatcase, the minimum number of farms to be visited annually must represent atleast one farm per 100 000 pigs slaughtered the previous year.

Each sub-group in Group A must be checked each year using a minimum of5 % of the total number of samples to be collected for Group A.

The balance will be allocated according to the experience and backgroundinformation of the Member State.

Group B: 0,03 %

The same breakdown per sub-group as for bovine animals has to berespected. The balance will be allocated according to the situation of theMember State.

3. Sheep and goats

The minimum number of animals to be checked for all kind of residues andsubstances must at least equal 0,05 % of sheep and goats over three monthsof age slaughtered the previous year, with the following breakdown:

Group A: 0,01 %

Each sub-group of Group A must be checked each year using a minimum of5 % of the total number of samples to be collected for Group A.

1996L0023 — EN — 01.05.2004 — 002.001 — 22

▼BThe balance will be allocated according to the experience and backgroundinformation of the Member State.

Group B: 0,04 %

The same breakdown per sub-group as for bovine animals has to berespected. The balance will be allocated according to the experience of theMember State.

4. Equine animals

The number of samples is to be determined by each Member State in relationto the problems identified.

CHAPTER 2

Broiler chickens, spent hens, turkeys, other poultry

A sample consists of one or more animals depending on the requirements of theanalytical methods.

For each category of poultry considered (broiler chickens, spent hens, turkeys,and other poultry), the minimum number of samples to be taken each yearmust at least equal one per 200 tonnes of annual production (deadweight), witha minimum of 100 samples for each group of substances if the annual produc-tion of the category of birds considered is over 5 000 tonnes.

The following breakdown must be respected:

Group A: 50 % of the total samples

The equivalent of one fifth of these samples must be taken at farm level.

Each sub-group of Group A must be checked each year using a minimum of 5 %of the total number of samples to be collected for Group A.

The balance will be allocated according to the experience and background infor-mation of the Member State.

Group B: 50 % of the total samples,

30 % must be checked for Group B 1 substances,

30 % must be checked for Group B 2 substances,

10 % must be checked for Group B 3 substances.

The balance will be allocated according to the situation of the Member State.

CHAPTER 3

Aquaculture products

1. Finfish farming products

A sample is one or more fish, according to the size of the fish in questionand of the requirements of the analytical method.

Member States must respect the minimum sampling levels and frequenciesgiven below, depending on the production of farmed fish (expressed intonnes).

The minimum number of samples to be collected each year must be at least 1per 100 tonnes of annual production.

The compounds sought and the samples selected for analysis should beselected according to the likely use of these substances.

The following breakdown must be respected:

Group A: one third of the total samples:

all the samples must be taken at farm level, on fish at allstages of farming (1), including fish which is ready to beplaced on the market for consumption.

1996L0023 — EN — 01.05.2004 — 002.001 — 23

▼B

Group B: two thirds of the total samples:

the sampling should be carried out:

(a) preferably at the farm, on fish ready to be placed on themarket for consumption;

(b) either at the processing plant, or at wholesale level, onfresh fish, on condition that tracing-back to the farm oforigin, in the event of positive results, can be done.

(1) For sea-farming, in which sampling conditions may be especially difficult, samplesmay be taken from feed in place of samples from fish.

In all cases, samples taken at farm level should be taken from a minimum of10 % of registered sites of production.

2. Other aquaculture products

When Member States have reason to believe that veterinary medicine orchemicals are being applied to the other aquaculture products, or when envir-onmental contamination is suspected, then these species must be included inthe sampling plan in proportion to their production as additional samples tothose taken for finfish farming products.

1996L0023 — EN — 01.05.2004 — 002.001 — 24

▼BANNEX V

Chapter 1

The following laboratories shall be designated Community reference laboratoriesfor the detection of residues of certain substances:

(a) For the residues listed in Annex I, Group A 1, 2, 3, 4, Group B 2 (d) andGroup B 3 (d)

Rijksinstituut voor Volksgezondheid en Milieuhygiëne (RIVM)A. van Leeuwenhoeklaan, 9NL-3720 BA Bilthoven

(b) For the residues listed in Annex I, Group B 1 and B 3 (e) and carbadoxresidues and olaquindox residues

Laboratories des médicaments vétérinaires (CNEVA-LMV)La Haute Marche, JaveneF-35135-Fougères

(c) For the residues listed in Annex I, Group A 5 and Group B 2 (a), (b), (e)

Bundesinstitut für Gesundheitlichen Verbraucherschutz und Veterinärme-dizin (BGVV)Diedersdorfer Weg, 1D-12277-Berlin

(d) For the residues listed in Annex I, Group B 2 (c) and Group B 3 (a), (b),(c):

Istituto Superiore di SanitàViale Regina Elena, 299I-00161-Roma

The compounds included in Group A 6, B 2 (f) and B 3 (f) are allocated to thedesignated Community reference laboratories, according to their pharmacolo-gical action.

Chapter 2

The powers and operating conditions of the Community reference laboratoriesfor the detection of residues in live animals, their excrement and body fluidsand in tissue, animal products, animal feed and drinking water shall be asfollows:

1. The functions of Community reference laboratories shall be:

(a) to promote and coordinate research into new analytical methods and toinform national reference laboratories of advances in analytical methodsand equipment;

(b) to help the national reference laboratories (NRLs) for residues to imple-ment an appropriate quality assurance scheme system based on goodlaboratory practice (GLP) principles and EN 45 000 criteria;

(c) to approve validated methods as reference methods, to be integrated intoa collection of methods;

(d) to provide the national reference laboratories with the routine analyticalmethods accepted during the MRL procedure;

(e) to provide national reference laboratories with details of analyticalmethods and the comparative tests to be conducted, and to inform themof the results of the tests;

(f) to provide national reference laboratories, at their request, with technicaladvice on the analysis of the substances for which they have been desig-nated the Community reference laboratory;

(g) to organize comparative tests for the benefit of the national referencelaboratories, the frequency of which shall be determined in agreementwith the Commission. Consequently, the Community reference labora-tories shall distribute blank samples and samples containing knownamounts of analyte to be analysed;

(h) to identify residues and determine their concentration in cases where theresults of an analysis give rise to a disagreement between MemberStates;

(i) to conduct initial and further training courses for the benefit of analystsfrom national laboratories;

1996L0023 — EN — 01.05.2004 — 002.001 — 25

▼B(j) to provide the Commission services, including the standards, measure-

ments and testing programme, with technical and scientific assistance;

(k) to compile a report on each year's work and transmit it to the Commis-sion;

(l) to liaise, in the field of analytical methods and equipment, with thenational reference laboratories designated by third countries in the plansto be submitted in accordance with Article 11 of this Directive.

2. In order to perform the functions specified in paragraph 1, Community refer-ence laboratories must satisfy the following minimum requirements:

(a) have been designated as a national reference laboratory in a MemberState;

(b) have suitable qualified staff who are adequately trained in analyticalmethods used for the residues for which they have been designated theCommunity reference laboratory;

(c) possess the equipment and substances needed to carry out the analysis forwhich they are responsible;

(d) have an adequate administrative infrastructure;

(e) have sufficient data-processing capacity to produce statistics based ontheir findings and to enable rapid communication of those statistics andother information to national reference laboratories and the Commission;

(f) ensure that their staff respect the confidential nature of certain issues,results or communications;

(g) have sufficient knowledge of international standards and practices;

(h) have available an up-to-date list of certified reference material and refer-ence material held by the Institute for Reference Material and Methods,and an up-to-date list of manufacturers and vendors of that material.

1996L0023 — EN — 01.05.2004 — 002.001 — 26

▼BANNEX VI

Correlation table

This Directive Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC

Article 1 —

Article 2 Article 2 86/469/EEC


Article 2 85/358/EEC


Article 5 Article 4 (1) first and second indents 86/469/EEC

Article 6 —

Article 7 Article 4 (1) except first and second indents 86/469/EEC

Article 8 Article 4 (2) to 4 (5) 86/469/EEC



Article 9 —

Article 10 —


Article 12 —



Article 14 (1) Article 8 (1) (b) 86/469/EEC

Article 14 (2) Article 8 (2) 86/469/EEC

Decision 91/664/EEC

Decision 89/187/EEC


Article 5 (2) 85/358/EEC


Article 5 (3) 85/358/EEC

Article 15 (3) Article 9 86/469/EEC

Article 16 Article 9 (1) and Article 9 (2) 86/469/EEC

Article 6 (1) and Article 6 (2) 85/358/EEC

Article 17 Article 9 (3) (a) 86/469/EEC

Article 6 (3) (a) 85/358/EEC

Article 18 Article 9 (3) (c) and (d) 86/469/EEC

Article 19 —

Article 20 (1) —

Article 20 (2) Article 11 86/469/EEC



Article 23 Articles 9 (3) (b) (c) (d) and 9 (4), 9 (5) 86/469/EEC

Articles 6 (3) (b) (c) (d) and 6 (4) 85/358/EEC


Article 25 —

Article 26 —

Article 27 —

Article 28 —



1996L0023 — EN — 01.05.2004 — 002.001 — 27

▼B

This Directive Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC

Article 30 —







Article 35 —

Article 36 —

Article 37 —

Article 38 —

Article 39 —

Annex I Annex I 86/469/EEC

Annex II —

Annex III —

Annex IV Annex II 86/469/EEC

Annex V Chapter 1 Decision 91/664/EEC

Annex V Chapter 2 Decision 89/187/EEC

Annex VI —

1996L0023 — EN — 01.05.2004 — 002.001 — 28

B COUNCILDIRECTIVE96/23/EC of29April1996 on measures to ...

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